Entries for Wednesday, June 20, 2001

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The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined that metformin hydrochloride (HCl) tablets (Glucophage), 625 and 750 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for metformin HCl 625- and 750-mg tablets.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This final rule grants a waiver of the end-stage renal disease conditions for coverage to permit the transplant team of an approved renal transplant center to furnish covered kidney transplant services in three specific hospitals in the Houston, Texas area during a state of emergency crisis.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is reopening until July 18, 2001, the comment period on its draft risk assessment on the relationship between Vibrio parahaemolyticus in raw molluscan shellfish and human health (66 FR 5517, January 19, 2001). Interested persons were initially given until March 20, 2001, with an extension to May 21, 2001 (66 FR 13546, March 6, 2001), to comment on the draft risk assessment. This reopening of the comment period is in response to a request from the National Fisheries Institute (NFI) on behalf of the Gulf Oyster Industry Council, the Pacific Coast Shellfish Growers Association, and the Molluscan Shellfish Institute. The agency does not anticipate further extensions of the comment period for this draft risk assessment.

This amendment rescinds an existing airworthiness directive (AD) that applies to Bell Helicopter Textron Canada (BHTC) Model 407 helicopters and currently requires, before further flight, imposing never exceed velocity (Vne) restrictions on the helicopter. The requirements of that AD were intended to prevent tail rotor blades from striking the tailboom, separation of the aft section of the tailboom with the tail rotor gearbox and vertical fin, and subsequent loss of control of the helicopter. That AD was prompted by an accident suspected of being the result of a tail rotor strike caused by high airspeed. Since the issuance of that AD, accident investigation findings have not substantiated that a tail rotor strike caused by high airspeed was the cause of the accident. This amendment rescinds that AD. This amendment is prompted by the FAA's determination that the Vne restrictions and accompanying actions imposed by that AD do not correct an unsafe condition.

This amendment adopts a new airworthiness directive (AD), applicable to certain Boeing Model 747-400 series airplanes, that requires an inspection to detect miswiring of diodes in the heating system of the pitot static probes, and corrective action, if necessary. The actions specified by this AD are intended to prevent reduced power to the heating system of the pitot static probes, leading to ice accumulation on the pitot static probes, which could result in erroneous airspeed or altitude indications to the flight crew, and consequent reduced operational safety in all phases of flight. This

This amendment adopts a new airworthiness directive (AD), applicable to certain CASA Model CN- 235 series airplanes, that requires modification of the rigging of the engine control cable assembly and replacement of either the entire engine control cable assembly or a segment of the control cables. This amendment is prompted by issuance of mandatory continuing airworthiness information issued by a foreign airworthiness authority. The actions specified by this AD are intended to prevent fatigue of the engine control cables, leading to breakage of the cables, which could result in reduced controllability of the airplane. This action is intended to

This amendment adopts a new airworthiness directive (AD), applicable to certain McDonnell Douglas Model MD-90-30 series airplanes, that requires revising the wiring of the selective calling (SELCAL) system. The actions specified by this AD are intended to prevent inadvertent very high frequency transmissions and subsequent loss of radio communications for airplane and/or airport operations; and to prevent inadvertent high frequency transmissions and subsequent electrical shock to ground service personnel and/or damage to the airplane during fueling operations or fuel tank maintenance. This

This amendment adopts a new airworthiness directive (AD), applicable to certain Raytheon Model Hawker 800XP series airplanes, that requires an inspection to confirm the installation of rivets at fuselage stations 251.975, 262.35, 272.725, and 283.10, and installation of new rivets, if necessary. The actions specified by this AD are intended to detect and correct fatigue cracking of the fuselage skin, and consequent loss of cabin pressurization. This action is

The Coast Guard is amending the operating regulations for the City of Seattle drawbridges across the Lake Washington Ship Canal and the Washington state drawbridge across the Duwamish Waterway in Seattle, Washington. The normal drawspan closed periods for Monday through Friday will now also be applied to Columbus Day to accommodate commuter traffic that remains heavy on this Federal holiday. Other Federal holidays remain exempted from the weekday closed periods.

This is a correction to an FAA notice that was published on June 12, 2001 (66 FR 31731). That notice requested comments on the feasibility and effectiveness of a limited number of demand management options that could replace the current temporary administrative limits on the number of aircraft operations at LGA which are scheduled to expire on September 15, 2001. The reasons for this correction is that the Port Authority of New York and New Jersey is making a correction in section 3 of the document that it submitted to the FAA, which was attached as an appendix to the June 12, 2001, Federal Register notice.

The FAA publishes a monthly notice, as appropriate, of PFC approvals and disapprovals under the provisions of the Aviation Safety and Capacity Expansions Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Pub. L. 101-508) and Part 158 of the Federal Aviation Regulations (14 CFR Part 158). This notice is published pursuant to paragraph d of Sec. 158.29.

This document grants in full the petition of General Motors Corporation (GM) for an exemption of a high-theft line, the Pontiac Grand Prix, from the parts-marking requirements of the Federal Motor Vehicle Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard.

This notice announces the availability of and requests comments on a proposed advisory circular (AC) which provides methods acceptable to the Administrator related to the certification requirements for windows, windshields, and mounting structures of 14 CFR part 25 regarding the type certification requirements for transport airplane structure. This notice is necessary to give all interested persons an opportunity to present their views on the proposed AC.

The Coast Guard is implementing safety zones for annual fireworks displays in the Captain of the Port Detroit Zone during July 2001. This action is necessary to provide for the safety of life and property on navigable waters during these events. These zones will restrict vessel traffic from a portion of the Captain of the Port Detroit Zone.

Temporary Special Local Regulations are being established for the Swimming Cross San Juan Harbor, San Juan, Puerto Rico. These regulations are needed to provide for the safety of life on navigable waters by excluding vessels from the swimming area.

Environmental Protection Agency (EPA or we) approves the following revisions to the Alaska State Implementation Plan (SIP): a revision of the visible emission limit for coal burning boilers, during startup; shutdown; soot-blowing; grate cleaning; or other routine maintenance activities, that began operation before August 17, 1971, and submitted the required demonstration. Additionally, we are approving a revision to the definitions section that will add definitions of grate cleaning and soot-blowing. The Alaska Department of Environmental Conservation (ADEC) forwarded this submittal to EPA for inclusion in the Alaska SIP on November 1, 1999. These revisions were submitted for the purposes of complying with section 110 of the Clean Air Act.

The EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the State of Alaska for the purpose of revising the visible emission limit for coal burning boilers, during startup; shutdown; soot-blowing; grate cleaning; or other routine maintenance activities, that began operation before August 17, 1971, and submitted the required demonstration. Additionally, we are proposing to approve a revision to the definitions section that will add definitions of grate cleaning and soot-blowing. The SIP revision was submitted by the State to satisfy certain Federal Clean Air Act requirements under Section 110. In the Final Rules Section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal amendment and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If the EPA receives adverse comments, the direct final rule will be withdrawn and all

California has applied to EPA for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has reviewed California's application and made the tentative decision that these changes satisfy all requirements needed to qualify for final authorization, and is proposing to authorize the State's changes.

EPA has granted experimental use permits (EUPs) to the following pesticide applicants. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.

EPA is withdrawing direct final approval of the recision of rules from the Pinal-Gila Counties Air Quality Control District (PGCAQCD) portion of the Arizona State Implementation Plan (SIP) that were published in the Federal Register on May 1, 2001 (66 FR 21675).

Notice is hereby given that the Rural Utilities Service (RUS) has made a finding of no significant impact with respect to a request for financing assistance by Arkansas Electric Cooperative Corporation to finance the repowering of an existing electric generating station in Franklin County, Arkansas.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau of Alcohol, Tobacco and Firearms within the Department of the Treasury is soliciting comments concerning the Tax Deferral Bond--Distilled Spirits (Puerto Rico).

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau of Alcohol, Tobacco and Firearms within the Department of the Treasury is soliciting comments concerning the Application For Permit Under 26 U.S.C. Chapter 52, Manufacturer of Tobacco Products Importer of Tobacco Products, or Proprietor of Export Warehouse and Application for Amended Permit Under 26 U.S.C. 5712, Manufacturer of Tobacco Products Importer of Tobacco Products, or Proprietor of Export Warehouse.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau of Alcohol, Tobacco and Firearms within the Department of the Treasury is soliciting comments concerning the Notice of Change in Status of Plant.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985, 22 U.S.C. 2459), the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236 of October 19, 1999, as amended, I hereby determine that the objects to be included in the exhibition ``Bernardo Bellotto and the Capitals of Europe,'' imported from abroad for the temporary exhibition without profit within the United States, are of cultural significance. These objects are imported pursuant to a loan agreement with the foreign lenders. I also determine that the exhibition or display of the exhibit objects at The Museum of Fine Arts, Houston from on or about July 29, 2001 to on or about October 21, 2001 is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985, 22 U.S.C. 2459), the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236 of October 19, 1999, as amended, I hereby determine that the objects to be included in the exhibition ``Gifts to the Tsars 1500- 1700, Treasures from the Kremlin,'' imported from abroad for the temporary exhibition without profit within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign lender. I also determine that the exhibition or display of the exhibit objects at the Indianapolis Museum of Art, Indianapolis, IN from on or about September 23, 2001 to on or about January 13, 2002, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

We, the U.S. Fish and Wildlife Service (Service), announces the availability of the draft economic analysis for the proposed determination of critical habitat for the Quino checkerspot butterfly (Euphydryas editha quino) and the reopening of the public comment period for the proposed determination to allow all interested parties to submit written comments on the proposal and on the draft economic analysis. Comments previously submitted need not be resubmitted as they have been incorporated into the public record and will be fully considered in the final rule. Additionally, we are announcing that a public hearing will be held on the proposed critical habitat determination.

OSM is approving, with exceptions, an amendment to the Kentucky regulatory program (Kentucky program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA). Kentucky is proposing revisions to the Kentucky Revised Statutes (KRS) pertaining to ownership and control, easement of necessity for the limited purpose of

OSM is announcing receipt of a proposed amendment to the West Virginia regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA). The program amendment consists of changes to the West Virginia Surface Coal Mining and Reclamation Act as contained in Senate Bill 603. The amendment concerns reclamation plan requirements and authorizes the submittal of a master land use plan for postmining land use. The amendment also revises the provisions concerning the Office of Coalfield Community Development. The amendment is intended to improve the effectiveness of the West Virginia program.

This notice sets forth objectives, procedures and application review criteria associated with the U.S. Department of Commerce's (DOC) International Buyer Program (IBP), to support domestic trade shows. Selection is for the International Buyer Program for Fiscal Year 2003 (October 1, 2002 through September 30, 2003).

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and the terms of the consent order-- embodied in the consent agreement--that would settle these allegations.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and terms of the consent order-- embodied in the consent agreement--that would settle these allegations.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and the terms of the consent order--embodied in the consent agreement--that would settle these allegations.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and the terms of the consent order-- embodied in the consent agreement--that would settle these allegations.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and the terms of the consent order-- embodied in the consent agreement--that would settle these allegations.

The Department of the Navy hereby gives notice of the general availability of exclusive or partially exclusive licenses under the following pending patent. Any license granted shall comply with 35 U.S.C. 209 and 37 CFR part 404. Applications will be evaluated utilizing the following criteria: (1) Ability to manufacture and market the technology; (2) manufacturing and marketing ability; (3) time required to bring technology to market and production rate; (4) royalties; (5) technical capabilities; and (6) small business status.

The Assistant Secretary for Elementary and Secondary Education reserves $2,300,000 for FY 2001 consortium incentive grant awards authorized under section 1308(d) of Title I of the Elementary and Secondary Education Act of 1965. (The FY 2001 Appropriations Act for the Department (P.L. 106-554) authorizes the Department to reserve up to $3,000,000 for these grant awards, notwithstanding the $1,500,000 ceiling in the authorizing statute). State educational agencies (SEAs) operating Migrant Education Programs (MEPs) are the only eligible entities for this formula grant program. Criteria for an SEA's receipt of consortium incentive grants were published in the Federal Register on April 8, 1996 (61 FR 15670).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and other federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95)(44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data is provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.